Minncare HD

GUDID 30677964079499

MEDIVATORS INC.

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Primary Device ID	30677964079499
NIH Device Record Key	deeb99a1-ec39-4518-9933-4775c98c7305
Commercial Distribution Status	In Commercial Distribution
Brand Name	Minncare HD
Version Model Number	3031105
Company DUNS	068199363
Company Name	MEDIVATORS INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964079498 [Primary]
GS1	30677964079499 [Package] Contains: 00677964079498 Package: [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133724

FDA Product Code

NIH	Disinfectant, Subsystem, Water Purification

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2018-01-09

On-Brand Devices [Minncare HD]

30677964079499	3031105
30677964066871	3029765
30677964066864	3029764
50724995223293	Minncare HD (4 x 1 Gallon)